NCT01703663

Brief Summary

Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy on sleep apnea severity among patients with recent ischemic stroke. Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control night. Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with nasal EPAP therapy compared with a control night.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 13, 2016

Completed
Last Updated

October 13, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

October 5, 2012

Results QC Date

May 19, 2016

Last Update Submit

August 19, 2016

Conditions

Ischemic StrokeObstructive Sleep Apnea

Keywords

StrokeSleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea Index

    Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.

    night 1 and night 2

Study Arms (2)

EPAP

EXPERIMENTAL

Provent Sleep Apnea Therapy.

Device: EPAP

control

NO INTERVENTION

Interventions

EPAPDEVICE
Also known as: Provent Sleep Apnea Therapy.
EPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults with an ischemic stroke (including TIA with infarction) within the prior 14 days

You may not qualify if:

  • Current use of any transnasal tube (eg dobhoff tube)
  • Current use of CPAP, mechanical ventilation, or supplemental oxygen
  • Known severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum
  • Severe heart disease (including severe heart failure)
  • Pathologically low blood pressure
  • An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
  • Sores, abrasions, or skin or mucosal irritation on or around the nose.
  • Known pregnancy
  • Inability to provide informed consent
  • Use of alpha blockers or short acting nitrates
  • Permanent pacemaker
  • Sustained non-sinus cardiac arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Wheeler NC, Wing JJ, O'Brien LM, Hughes R, Jacobs T, Claflin E, Chervin RD, Brown DL. Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial. J Clin Sleep Med. 2016 Sep 15;12(9):1233-8. doi: 10.5664/jcsm.6120.

    PMID: 27306393DERIVED

MeSH Terms

Conditions

Ischemic StrokeSleep Apnea, ObstructiveStrokeSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Results Point of Contact

Title
Devin L. Brown, MD, MS
Organization
University of Michigan
devinb@umich.edu
734-936-9075

Study Officials

  • Devin L Brown, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 5, 2012

First Posted

October 10, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 13, 2016

Results First Posted

October 13, 2016

Record last verified: 2016-08

Locations

US(1)